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Intradermal HIV-1 DNA immunization using needle-free ZetajetTM injection followed by HIV-modified vaccinia virus Ankara vaccination is safe and immunogenic in Mozambican young adults: a phase I randomized controlled trial
Instituto Nacional de Saúde, Maputo, Mozambique; Karolinska Institutet, Division of Clinical Microbiology, Department of Laboratory Medicine, Huddinge, Sweden; Universidade Eduardo Mondlane, Maputo, Mozambique.
Instituto Nacional de Saúde, Maputo, Mozambique; Karolinska Institutet, Division of Clinical Microbiology, Department of Laboratory Medicine, Huddinge, Sweden; Universidade Eduardo Mondlane, Maputo, Mozambique.
Karolinska Institutet, Division of Clinical Microbiology, Department of Laboratory Medicine, Huddinge, Sweden; Folkhalsomyndigheten, Solna, Stockholm, Sweden.
Instituto Nacional de Saúde, Maputo, Mozambique.
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2017 (English)In: AIDS Research and Human Retroviruses, ISSN 0889-2229, E-ISSN 1931-8405Article in journal (Refereed) Epub ahead of print
Abstract [en]

We assessed safety and immunogenicity of HIV-DNA priming using Zetajet<sup>TM</sup>, a needle-free device intradermally followed by intramuscular HIV-MVA boosts, in 24 healthy Mozambicans. Volunteers were randomized to receive three immunizations of 600 µg (n = 10; 2 x 0.1mL) or 1200 µg (n = 10; 2 x 0.2mL) of HIV-DNA (3 mg/mL), followed by two boosts of 10<sup>8</sup>pfu HIV-MVA. Four subjects received placebo saline injections. Vaccines and injections were safe and well tolerated with no difference between the two priming groups. After three HIV-DNA immunizations, IFN-γ ELISpot responses to Gag were detected in 9/17 (53%) vaccinees, while none responded to Env. After the first HIV-MVA, the overall response rate to Gag and/or Env increased to 14/15 (93%); 14/15 (93%) to Gag and 13/15 (87%) to Env. There were no significant differences between the immunization groups in frequency of response to Gag and Env or magnitude of Gag responses. Env responses were significantly higher in the higher-dose group (median 420 vs 157.5 SFC/million PBMC, p=0.014). HIV-specific antibodies to subtype C gp140 and subtype B gp160 were elicited in all vaccinees after the second HIV-MVA, without differences in titers between the groups. Neutralizing antibody responses were not detected. Two (13%) of 16 vaccinees, one in each of the priming groups, exhibited antibodies mediating antibody-dependent cellular cytotoxicity to CRF01_AE. In conclusion, HIV-DNA vaccine delivered intradermally in volumes of 0.1-0.2 mL using Zetajet<sup>TM</sup> was safe and well tolerated. Priming with the 1200 µg dose of HIV-DNA generated higher magnitudes of ELISpot responses to Env.

Place, publisher, year, edition, pages
Mary Ann Liebert, 2017.
Keywords [en]
HIV, vaccine, Mozambique, HIV-DNA, HIV-MVA
National Category
Infectious Medicine Immunology in the medical area
Identifiers
URN: urn:nbn:se:oru:diva-61451DOI: 10.1089/AID.2017.0121ISI: 000417253800001PubMedID: 28969431OAI: oai:DiVA.org:oru-61451DiVA, id: diva2:1150575
Note

Funding Agencies:

NIH  AI064518 

European and Developing Countries Clinical Trials Partnership  CT.200633111.007 

Regional HIV/AIDS Team for Africa, Embassy of Sweden, Lusaka  

Sida  2150012801 

Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.  W81XWH-07-2-0067  W81XWH-11-0174 

U.S. Department of Defense (DOD)  

U.S. National Institutes of Health  NCT01407497 

Pan African Clinical Trials Registry  PACTR201106000304583 

Available from: 2017-10-19 Created: 2017-10-19 Last updated: 2018-01-13Bibliographically approved

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